[Project Title]

Muhammad Farooq Shaikh. Student, Dr Nigel Stocks. Second Supervisor, Dr Davide Piaggio. Supervisor

SCOPE OF THE RESEARCH health and participation in cognitive and educational

General Area of Research: activities.

Learning disabilities and neural developmental disorders Digital Therapeutic Platforms: Web-based platforms
in children has some challenges which requires special and software programs that provide evidence-based
assistance for those children suffering from learning interventions as well as cognitive training along personality
disabilities like Dyslexia, Dysgraphia, Dyscalculia, ADHD, therapies aiming at specific learning constraints such as
etc. which are multifactorial genetic-environmental disorders dyslexia, dyscalculia, or attention-deficit hyperactivity
highly common in society (Rello et al., 2020, Alt et al., disorder (ADHD).
2017). The prevalence of learning difficulties, a complex
hereditary and environmental condition, ranges from 5% to
20%.
Due to diagnostic and screening challenges specially at
an early age (because of expensive costs, lengthy wait times,
and remote locations), underdiagnosis is a serious issue that
causes anxiety, behavioral problems, insecurity, and high
rates of school dropout and unemployment (García-Redondo
et al., 2019, Heller et al., 2013). To overcome these
challenges and barriers this project aims to develop a novel
health technology solution that would help to improve the
outcomes of patients and healthcare efficiency in pediatric
neurology by designing and testing a Class IIa medical
device available for a population of kids of 5-7 years old
(Jafarlou et al., 2020).
Class IIa medical devices that will be beneficial to the
children with learning disabilities, the solutions that will be Figure 1: Classification of all medical devices with the
provided through technological intervention will be utilized potential risk meter.
for screening, diagnosing, manage, and assist the children
with learning disabilities accordingly. Some examples could Smart Assistive Devices: Smart pens for reading, audio
be: aids for dead words, graphic display of text-to-speech, voice
recognition, and optical character recognition (OCR)
Neurodevelopmental Screening Devices: The devices capabilities to facilitate students with reading, writing, and
create scientifically sound and capable, portable tools for note taking as well.
healthcare professionals to be able to measure cognitive and
developmental milestones, detect learning disabilities early Remote Monitoring Systems: Telemedicine platforms
on, and provide their feedback. and remote monitoring systems with a possibility of medical
professionals to carry out an evaluation, closely supervise
Digital Assessment Tools: The creation of the user- and control the progress of children with learning disabilities
friendly computer applications or platforms to facilitate the by, for instance, by providing teletherapy sessions and
assessment of cognitive ability, adaptive learning programs, support to parents and educators.
or neurofeedback training, adapted to the needs of the
children with learning problems.
Assistive Communication Devices: AAC systems with
symbols, illustrations, or the ability to convert text to speech
feature for children who have problems with language or
communication and hence they can express themselves
accurately.
Educational Apps and Games: Maintaining gradual
progress, introducing novel visuals, and employing diverse
sounds allow the child to be engaged in the task. Emphasis
can be put on mobile applications or computer games
specifically designed to support learning and cognitive
development of the child with disabilities, offering
personalized learning experiences and adaptive content.
Wearable Technologies: Wearable devices fitted out
with sensors for monitoring vital marks or faculties,
recording behavioral trends or supplying feedback in real-
time to guardians and healthcare experts on child's overall Figure 2: Classification of all in-vitro diagnostic medical
devices with the potential risk meter.
 These medical devices that belong to the class IIa are verify its efficiency and decentralized data acquisition
intended to provide the kids with learning difficulties with a protocols. Finally, this project is intended to provide the
better environment in the identification, assessment, state-of-the-art health technology solution, which aims to
intervention and support services to cover a larger spectrum eliminate the underdiagnosis of learning disabilities and to
of their needs and remedy their conditions so as to help them help improve patients' outcomes in pediatric neurology
in their education and quality of life. (SlobodinYahav and Berger, 2020).
Overview of the Technologies and Processes that will REFERENCE LIST
be used (tentative):
ALT, M., HOGAN, T., GREEN, S., GRAY, S., CABBAGE,
Nowadays, assessing and treating learning disabilities K. & COWAN, N. 2017. Word learning deficits in
follow conventional diagnostic techniques that are time- children with dyslexia. Journal of Speech,
consuming, costly, and have limited accessibility. The Language, and Hearing Research, 60, 1012-1028.
project aims to adapt the benefits of medical device GARCÍA-REDONDO, P., GARCÍA, T., ARECES, D.,
technology and artificial intelligence to create a user-friendly, NÚÑEZ, J. C. & RODRÍGUEZ, C. 2019. Serious
rapid, and portable screening device that tackles these games and their effect improving attention in
limitations (Niemelä et al., 2020). Integrating smart
students with learning disabilities. International
functionalities like intelligent risk classifications,
Journal of Environmental Research and Public
personalized regimens, and real-time monitoring of drug
adherence, our proposed solution is intended to optimize the Health, 16.
diagnostic process and enhance patient care HELLER, M. D., ROOTS, K., SRIVASTAVA, S.,
(RauschenbergerBaeza-Yates and Rello, 2022, Schmitt et al., SCHUMANN, J., SRIVASTAVA, J. & HALE, T.
2018). S. 2013. A Machine Learning-Based Analysis of
Game Data for Attention Deficit Hyperactivity
Current State of the Art: Disorder Assessment. Games for Health Journal, 2,
Currently, the state of the art in this area is the use of 291-298.
clinical evaluations, behavioral observations, and JAFARLOU, F., JAROLLAHI, F., AHADI, M. &
standardized tests to diagnose learning disabilities and SADEGHI-FIROOZABADI, V. 2020. Effects of
disorders. In recent studies technology is also being oculomotor rehabilitation on the cognitive
considered as a solution to the problems that originate from performance of dyslexic children with concurrent
the classical medical methods of diagnosis (van de Ven et al., eye movement abnormalities. Early Child
2017). This research aims to contribute by suggesting a new Development and Care, 1-13.
health technology solution that has a chance to outperform LARCO, A., CARRILLO, J., CHICAIZA, N., YANEZ, C. &
the current techniques of care and bring diagnostic services LUJÁN-MORA, S. 2021. Moving beyond
closer to children diagnosed with learning disabilities. limitations: Designing the helpdys app for children
Research Questions and Issues: with dyslexia in rural areas. Sustainability
(Switzerland), 13.
 What could be the ways to use technology to address the NIEMELÄ, M., KÄRKKÄINEN, T., ÄYRÄMÖ, S.,
diagnosis and management of learning disabilities in RONIMUS, M., RICHARDSON, U. &
children? LYYTINEN, H. 2020. Game learning analytics for
 What could be the main features and requirements of a understanding reading skills in transparent writing
screening device that can be easily accessed, fast, and system. British Journal of Educational Technology,
simple for patients and healthcare professionals to use? 51, 2376-2390.
RAUSCHENBERGER, M., BAEZA-YATES, R. & RELLO,
 What could be the user-friendly design approach which L. 2022. A Universal Screening Tool for Dyslexia
ensures the diversity of the targeted patients, healthcare by a Web-Game and Machine Learning. Frontiers
providers, and stakeholders’ needs and preferences are
in Computer Science, 3.
fulfilled?
RELLO, L., BAEZA-YATES, R., ALI, A., BIGHAM, J. P.
 What could be the ethical and regulatory challenges and & SERRA, M. 2020. Predicting risk of dyslexia
issues for designing and using a class IIa medical device with an online gamified test. PLoS ONE, 15.
for detecting neurodevelopmental disorders? SCHMITT, K. L., HURWITZ, L. B., SHERIDAN DUEL, L.
 What could be the effects of the proposed clinical & NICHOLS LINEBARGER, D. L. 2018. Learning
decision support system to improve the patient's through play: The impact of web-based games on
outcomes and increase healthcare efficiency as early literacy development. Computers in Human
compared to the current state of the art methods? Behavior, 81, 378-389.
SLOBODIN, O., YAHAV, I. & BERGER, I. 2020. A
Overview of Research Project: Machine-Based Prediction Model of ADHD Using
The research project will include the design, CPT Data. Frontiers in Human Neuroscience, 14.
development, and validation of class IIa medical device for VAN DE VEN, M., DE LEEUW, L., VAN
screening neurodevelopmental disorders of 5-7 years old WEERDENBURG, M. & STEENBEEK-
children. The project together with PBH (PaperBox Health) PLANTING, E. G. 2017. Early reading intervention
and the University of Warwick will dig deep into the by means of a multicomponent reading game.
expertise to produce the prototype of the proposed Clinical Journal of Computer Assisted Learning, 33, 320-
Decision Support system (Larco et al., 2021). This system 333.
will be subjected to a strict trial in a real-world clinical
setting using a randomized double-blinded controlled trial to
 OBJECTIVES for screening neurodevelopmental disorders in children aged
During the period of this study, the following objectives 5 to 7 years. Activities will be planning a thorough
will be pursued: systematic literature review, creation of methodologies,
doing a prototype Clinical Decision Support system design,
 Perform a thorough systematic literature review on the assurance of regulatory compliance, conducting real-world
recent developments in pediatric neurology, testing, and analyzing data. The primary goal is to address
concentrating on the diagnosis and treatment of learning the concerning issue of the lack of awareness of learning
disabilities, as well as on the genetic and environmental disorders, which will enhance patient outcomes and
aspects of these diseases. healthcare efficiency.
 Use the proper research methodology on the relevant Year 1 Activities:
topic, such as data collection techniques, statistical
Month 03/24-04/24:
analysis, and ethical issues of conducting research with
children.  In depth study of learning disorders and Class 2a medical
devices, such as scanning and electronic medicine for
 Work in a close collaboration with the team including
diagnosis and management.
computer scientists, biomedical engineers, bioethicists,
etc. at PaperBox Health S.r.l (PBH) and the University  Review the recent articles and books to reveal the
of Warwick, particularly the ABSPIE Lab, to study the essential ideas and identify the research gaps/directions.
current DINO solution and its constraints and develop
the confidence with the user-centered design principles. Month 05/24-06/24:

 Construct a view of the regulatory regulation and  Learn how to use technology for tackling the learning
certification processes that are associated with the disorders to have an understanding of today's approach
medical device development with particular attention to and the newest findings.
EU 2017/745 standards for Class IIa devices. How can  Assess the ability and issues/challenges of the current
these be tackled and overcome? technological interventions for learning disabilities.
 Design and develop the Clinical Decision Support Month 05/24-08/24:
prototype, the focus will be on the user interface design,
the feature selection, and the initial testing of the key Outline: Systematic Review of Learning Disabilities and
functionalities such as the risk classification index and Technological Interventions.
the personalized dosing instructions.  Carry out in-depth review of scientific literature on
 Standardization of protocols and processes to be followed learning disorders, and current technologies deployed.
in the real-world testing of the prototype in a clinical  Integrate the facts from the literature into a research plan,
setting, including recruitment of participants, data which actually suits the attributes of a successful study.
collection methods, and ethical approval.
Month 09/24-12/24:
 The process of data analysis and interpretation as an
initial step will be prioritized, with the aim of assessing  As a Graduate Teaching Assistant (GTA), I aim to gain
the prototype's ability to improve patient outcomes and valuable skills and insights that will be beneficial for my
healthcare efficiency more than the current standard of future career and personal growth.
care and state of the art techniques.  Perform assigned duties as the Teaching Assistant for
 Stay in touch with the latest developments in the fields of fresh graduates on different research topics and projects
pediatric neurology, health technology, and medical while providing research assistance.
device development by participating in conferences,  Go after the students and staff to promote academic
workshops, and seminars, and contribute to the scholarly assignments and be part of the academic community.
discourse in the field by being an active participant. From any college or university student’s perspective,
 Maintain the documentation to record the progress, research papers are crucial assignments that test their
findings, and challenges encountered during the research critical thinking, writing, and analytical skills.
process for the purpose of future publications and Month 06/24-08/24:
presentations.
 Work with the research team to explore the scientific
 Create regular communication and partnership with the options for researching and overcoming the challenges
supervisory team, industry partners, and fellow related to the learning disorders.
academic personnel for the purpose of the guidance,
feedback, and support in the achievement of the research  Engage in discussions and brainstorming sessions with
objectives and milestones. the research team to gain more creative ideas for the
proposed study.
RESEARCH PLAN
Month 08/24-09/24:
Overview:
 Completion of analysis of the studies and the reviews
The year of research for the upcoming year will be conducted.
focused on designing, developing and validating a novel
health technology solution addressing learning disabilities in  Review findings of research works during the literature
pediatric neurology improvement. With the support of co- review phase to pull out essential ideas and outcomes.
founder Paperbox Health S.r.l (PBH) and the University of
Warwick, the project will develop a Class IIa medical device
 Integration of data from different sources that will enable Month 08/24-12/24:
this research to find the solutions of the research
Make the very first Prototype:
questions.
 Undertake the progress of the first prototype of the
Month 08/24-10/24:
Clinical Decision Support system for learning disorders
 Build a strategy and link with experts to participate tool in diagnosis and management.
together.
 Work in team with colleagues who belong to different
 Outline an additional research strategy among the disciplines for deploying, improving, and testing the
identified research gaps and summarized literature prototype.
review.
Month 12/24-02/25:
 Another source of the knowledge can be the experts in Testimony and Data collection activities (in a testing
the field, who can comment on the research direction or mode):
give some advice (could be supervisors and mentors).
 Initialize the trial of your prototypes with clearly drawn
Month 10/24-11/24:
up regulations and policies for testing it in a controlled
 Track down forbidden Regulatory challenges, issues, and testing environment.
obstacles.
 Gather the results of the final product performance in a
 Evaluate guidelines for the development of devices for testing environment to measure the effectiveness and the
learning disorders in terms of regulatory demands and usability.
those factors that could become a hurdle in and during Month 07/24-10/24:
the process.
 Take note of the annual meeting by collecting progress
 Follow the advice of the regulatory specialists to see how reports, rehearsing presentations, and sharing findings
our product fits into regulatory standards and with the academic and administrative committees in the
regulations. research institution (supervisors and mentors).
Month 11/24-12/24:
 Review the accomplishments and milestones achieved
Ethical Approvals: during the first year of this research project.
 Patients/person to be studied openly would require the  Submit the 1st annual report.
consent of the relevant ethics committees.
Prepare proposals for publishing papers in peer-reviewed
 Make sure that protocols get ethical approval in journals and presentations at conferences and seminars.
accordance with these guidelines and principles. The Gantt chart provides a visual representation of the
planned activities over the course of the first year. Activities

Gantt Chart
4 4 4 4 4 4 5
/2 /2 /2 /2 /2 /2 /2
02 04 06 08 10 12 02

Review: Learning Disorders and use of Class 2a medical devices

Review: Technology based Solution for Learning Disorders

Review: Systematic Literature Review on Learning Disorders and solutions based on
technologies
Graduate Teaching Assistant (GTA)

Identifying Scientific Approaches by working with the team

Analysis of the reviews and studies conducted

Develop a further strategy and reach out to engage with experts

Identify possible Regulatory issues and challenges

Ethical Approvals

Develop a first Prototype

Testing and Data collection (in a testing environment)

Annual Review Preparation

Start Date Duration

may overlap, and timelines are subject to adjustments based
on progress and evolving project requirements. Regular Skills, to enhance communication and project management
meetings with the supervisory team and industry partners skills crucial for successful research.
will ensure alignment with project objectives and milestones. Conferences & Networking:
Present research findings at relevant conferences and
PROFESSIONAL & RESEARCH DEVELOPMENT
symposiums, including the Warwick School of Engineering
For the forthcoming year, I intend to engage in a variety of Postgraduate Symposium and other academic gatherings
professional and research development activities, focused on medical device engineering and pediatric
encompassing Research Skills, Transferable Skills, and neurology.
Conferences & Networking. These activities are aimed at Attending international conferences and workshops
enhancing my capabilities and expanding my network related to healthcare innovation and frugal engineering,
within the academic and professional community. aiming to establish connections with experts and
Research Skills: stakeholders in the field and gain insights into global best
Undertake a training course on advanced statistical practices.
analysis methods relevant to medical device research, Publication and Paper Writing:
focusing on data interpretation and presentation. Continue working on the journal paper based on the
Attend workshops and seminars on emerging technologies systematic literature review conducted in the early stages of
and methodologies in pediatric neurology and medical the PhD, aiming for publication in a reputable peer-reviewed
device engineering, particularly those applicable to the journal.
proposed research project. Collaborate with supervisors and industry partners to
Participate in the risk assessment/COSHH workshop and identify opportunities for co-authored publications and
PhD Research Showcase. contribute to the dissemination of research findings in
Transferable Skills: academic and industry forums.
Enroll in the Postgraduate Certificate in Transferable By actively participating in these professional and
Skills in Science (PGCTSS) offered by the University of research development activities, I aim to broaden my
Warwick, focusing on modules such as Doctoral Skills and knowledge base, refine my skills, and establish myself as a
Team Working in a Research Environment. competent and engaged researcher in the field of medical
Participate in RSSP courses, including Effective device engineering and pediatric neurology.
Researcher - The Essentials, and Practical Presentation